Perfusion balloon design

Patent metadata

Field	Value
Publication number	US-12364600-B2
Application number	US-202217956527-A
Country	US
Kind code	B2
Filing date	Sep 29, 2022
Priority date	Sep 16, 2015
Publication date	Jul 22, 2025
Grant date	Jul 22, 2025

Abstract

Disclosed herein are designs for improved inflatable structures for use during minimally invasive cardiovascular procedures. These inflatable structures facilitate the perfusion of blood through an anatomical structure, such as a heart valve, during the cardiovascular procedure. The inflatable structures are formed of a plurality of balloons arranged radially around a central location. The plurality of balloons form a lumen through which blood flows. Each balloon of the plurality is shaped or configured to stabilize the adjacent balloons, limiting their movement relative to each other. For example, some embodiments can feature balloons with a keystone shape that limits movement of the balloons inward toward the lumen. Some implementations can also include a support coil running through the lumen. The support coil holds enables the lumen to be open to perfusion even in the early stages of balloon inflation.

First claim

What is claimed is:

1. A balloon catheter for insertion into a body lumen with blood flowing therethrough, the balloon catheter comprising:
an elongate member defining an inflation lumen, the elongate member having a proximal end and a distal end;
an inflatable structure comprising a plurality of balloons coupled to the distal end of the elongate member and connected in fluid communication with the inflation lumen of the elongate member; and
a support coil coupled to the distal end of the elongate member, the support coil having a dumbbell shape and extending along a central axis within the perfusion lumen and at least partially supporting the balloons;
wherein the balloons are arranged circumferentially about the central axis so as to form a perfusion lumen extending along the central axis and wherein the perfusion lumen is configured to allow passage of the blood therethrough;
wherein each of the balloons is configured to inflate into a wedge-like shape, the wedge-like shape comprising at least two substantially straight side portions extending radially relative to the central axis; and
wherein an exterior surface of the inflatable structure is formed by the plurality of balloons.

2. The balloon catheter of claim 1 , wherein each of the balloons is molded into the wedge-like shape.

3. The balloon catheter of claim 1 , wherein each of the balloons naturally inflates into the wedge-like shape.

4. The balloon catheter of claim 1 , wherein at least one of the balloons includes at least one web extending through an interior portion of the balloon to connect a first substantially straight side portion to a second substantially straight side portion.

5. The balloon catheter of claim 1 , further comprising a prosthetic heart valve crimped over the inflatable structure.

6. The balloon catheter of claim 5 , wherein the prosthetic heart valve is in direct contact with the balloons.

7. The balloon catheter of claim 1 , wherein the dumbbell shape of the support coil includes a tubular central region extending between opposing bulbous end regions.

8. The balloon catheter of claim 7 , wherein a pitch of the support coil at the bulbous end regions is greater than a pitch of the support coil at the tubular central region to facilitate passage of the blood therethrough each of the bulbous end regions.

9. The balloon catheter of claim 1 , wherein the each of the two side portions converge toward each other extending toward the central axis.

10. The balloon catheter of claim 1 , wherein the wedge-like shape further comprises an inner portion extending between a radially inward end of each of the two side portions and an outer portion extending between a radially outward end of each of the two side portions.

11. The balloon catheter of claim 10 , wherein the inner portion defines a portion of the perfusion lumen.

12. The balloon catheter of claim 1 , wherein ends of the balloons have openings defined therebetween, the openings establishing fluid communication between the perfusion lumen and the blood in the body lumen.

13. The balloon catheter of claim 12 , wherein the ends of the balloons taper to small diameter tubes and are combined into a manifold in communication with the inflation lumen of the elongate member.

14. The balloon catheter of claim 1 , further comprising a plurality of interlocking mechanisms, wherein one interlocking mechanism is positioned between each adjacent pair of the balloons.

15. The balloon catheter of claim 1 , further comprising a surrogate valve configured to block openings defined between ends of the balloons to prevent backflow of blood.

16. The balloon catheter of claim 15 , wherein the surrogate valve includes a plurality of leaflets configured to extend over the openings during backflow of blood.

17. The balloon catheter of claim 16 , wherein the leaflets are further configured to deflect away from the openings during forward flow of blood.

18. A prosthetic valve delivery system for insertion into a body lumen with blood flowing therethrough, the delivery system comprising:
an elongate member defining an inflation lumen, the elongate member having a proximal end and a distal end;
an inflatable structure comprising a plurality of balloons coupled to the distal end of the elongate member and connected in fluid communication with the inflation lumen of the elongate member, the plurality of balloons forming an exterior surface of the inflatable structure;
a support coil coupled to the distal end of the elongate member, the support coil having a dumbbell shape and extending along a central axis within the perfusion lumen and at least partially supporting the balloons; and
a prosthetic heart valve crimped over the inflatable structure in direct contact with the balloons;
wherein the balloons are arranged circumferentially about the central axis so as to form a perfusion lumen extending along the central axis and wherein the perfusion lumen is configured to allow passage of the blood therethrough;
wherein each of the balloons comprises a non-circular cross-sectional shape having at least two substantially straight side portions extending radially relative to the central axis; and
wherein each substantially straight side portion at least partially abuts the substantially straight side portion of an adjacent one of the balloons.

19. A method of using a balloon catheter, the method comprising:
flowing fluid through the balloon catheter of claim 1 ;
inflating the balloons, each balloon taking a wedge-like shape upon inflation;
expanding a prosthetic valve via forces transmitted directly from exterior surfaces of the plurality of balloons; and
perfusing a second fluid from one end of the circumferentially adjacent arrangement of balloons, through the perfusion lumen and to another end of the circumferentially adjacent arrangement of balloons.

Assignees

• Edwards Lifesciences Corp

Inventors

• Zhu Yidong M
• Bulman Erik
• Bian Baigui
• Sok Sam
• Zhou Pu

Classifications

• A61M2025/1097

  with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon · CPC title

• A61M25/1011

  Multiple balloon catheters · CPC title

• A61M2025/1095

  with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft · CPC title

• A61M2025/1086

  having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves · CPC title

• A61M25/1002

  characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence) · CPC title